EMEA-001405-PIP01-12 - paediatric investigation plan

metoprolol (tartrate)

ivabradine hydrochloride

Key facts

• Active Substance:
  • metoprolol (tartrate)
  • ivabradine hydrochloride
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0129/2013
• PIP number:
  EMEA-001405-PIP01-12
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of ischaemic coronary artery disorders
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Les Laboratoires Servier

  E-mail: [e-mail] ; Tel. [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/05/2013

Decision

P/0129/2013: EMA decision of 28 May 2013 on the granting of a product-specific waiver for ivabradine (hydrochloride) / metoprolol (tartrate) (EMEA-001405-PIP01-12)

AdoptedReference Number: EMA/250331/2013